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Internal Quality Auditor

Internal Quality Auditor

The Judge Group Inc.Lewisville, TX, US
16 days ago
Job type
  • Full-time
Job description

Our client is currently seeking a Engineering Consultant

Top 5 Qualifications

  • Investigations, Root Cause Analysis, or Corrective Actions - Critical
  • Experience in Computer System Validation - Critical
  • Annual Product Review - Would be Nice
  • Experience with Validation, Process, Cleaning, or Equipment Validation - Would be Nice
  • Experience with Stability Programs - Would be Nice

Preferred Certifications :

  • Certified Quality Auditor
  • Certified Quality Engineer
  • Certified Quality Manager

    • Job Summary

    The role serves as a technical / subject matter expert for compliance quality-related issues and works to resolve these issues while improving quality globally. As an internal auditor and member of the Quality Systems team, the individual will assist in the day-to-day operations of Quality Systems processes, including :

  • Batch Record Review
  • Over-the-Counter (OTC) Drug and Nutritional Product Release
  • Annual Product Review (APR)
  • Validation Support
  • Change Control
  • Training
  • Document Control & Distribution
  • Investigation & Root Cause Analysis
  • Inspection Readiness

    • Key Responsibilities

    Quality Management System (QMS)

  • Oversee batch record review, document control, change control, annual OTC product review, validation support, and stability support.
  • Investigate and review quality events and market quality concerns.
  • Assist in process improvement initiatives to streamline compliance requirements and incorporate best practices.
  • Support special projects aligned with business and compliance goals.

    • Inspection Readiness

  • Stay updated on global regulatory changes that could impact Mary Kay products.
  • Assist in the implementation, monitoring, and maintenance of compliance policies and procedures.
  • Ensure compliance with global Quality standards and conduct internal audits of Mary Kay manufacturing centers and subsidiaries.
  • Provide audit support for FDA, TDH, Health Canada, and other external regulatory agencies.

    • Root Cause Analysis

  • Perform investigations into product quality issues, identifying root causes and implementing corrective actions.
  • Support failure investigations across Quality, R&D, Manufacturing Operations, Purchasing, Package Engineering, and Legal.
  • Ensure long-term systemic resolution and monitor the effectiveness of implemented changes.

    • Internal Auditor

  • Serve as an internal auditor, ensuring that the site operates in compliance with regulations.
  • Develop audit plans and execute audits, documenting findings and corrective action plans as necessary.
  • Assess manufacturing processes and work collaboratively with internal departments to ensure Mary Kay Quality Standards are upheld.

    • Skills & Experience

  • Experience : 3+ years in quality assurance or quality control
  • Education : Bachelor's / University Degree - Field of Study : Chemistry, Microbiology
  • Decision Making : Uses judgment based on information analysis

    • Additional Skills & Abilities

  • Strong understanding of advanced quality principles, audit protocols, inspection procedures, FDA and cGMP regulations.
  • Knowledge of OTC product compliance and various manufacturing processes / formulations.
  • Ability to apply advanced concepts and theories to develop new systems and principles.
  • Critical thinking & time management to analyze and solve complex problems.
  • Effective oral and written communication skills for interaction with personnel across various cultures.
  • Capable of independent decision-making with minimal supervision.
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    Internal Auditor • Lewisville, TX, US